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Allergic Rhinitis Due to Grass PollensNCT01889875

Immunological Comparison of AIT and SCIT Immunotherapy Against Grass Pollen

A study testing ALK Grazax 75,000 SQ-T "Phleum pratense" and ALK AluTard 225 "Phleum pratense" in people with Allergic Rhinitis Due to Grass Pollens, run by Bispebjerg Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Treatment of pollen allergies can be roughly divided into symptomatic treatment (e.g. antihistamines, steroids) and potentially curative immunotherapy. Immunotherapy can be delivered using subcutaneous or oral (mucosal) routes, with similar clinical outcome. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Allergic Rhinitis Due to Grass Pollens
What is being tested?
ALK Grazax 75,000 SQ-T "Phleum pratense" and ALK AluTard 225 "Phleum pratense"
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteDenmark
Study dates
Nov 2010to Aug 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • history of rhinitis with hay fever symptoms during the grass pollen season,
  • a skin-prick-test-verified grass pollen allergy (Phleum pratense),
  • eligibility for immunotherapy based on ARIA guidelines

Who cannot join

  • current long-term systemic steroid treatment,
  • previous immunotherapy,
  • asthma and outside-season airway hyperresponsiveness (AHR) (September 2011),
  • pregnancy,
  • negative RAST for grass, and
  • treatment side effect

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Bispebjerg University Hospital

    Copenhagen NV, Denmark, 2400

Other trials in Denmark

About this study

Treatment of pollen allergies can be roughly divided into symptomatic treatment (e.g. antihistamines, steroids) and potentially curative immunotherapy. Immunotherapy can be delivered using subcutaneous or oral (mucosal) routes, with similar clinical outcome. The study seeks to compare immunological changes during subcutaneous (SCIT) and sublingual tablet (AIT) immunotherapy of grass pollen allergy (hayfever).

Read the detailed description

Worldwide, more than 400 million people have allergic rhinitis, and sick-leave due to this condition costs societies billions of dollars annually1. Allergic rhinitis is most commonly treated with oral antihistamines and intranasal corticosteroids2. For moderate-severe rhinitis with poor control on topical treatment, immunotherapy should be considered3. Allergen immunotherapy is the only disease-modifying treatment available for IgE mediated allergy.

Immunotherapy is most commonly administered with subcutaneous injections of SQ-standardized allergen extracts (SCIT) and to a lesser extent, as sublingual drops (SLIT). However, other options now exist with the newly developed sublingual allergen immunotherapy tablets (AIT). The clinical effect of AIT4 and SCIT5 against grass pollen allergy has been demonstrated in large double-blind-placebo-controlled registration trials. These studies report significant reductions of symptom scores (AIT 30%, SCIT 32%) and seasonal rescue medication scores (AIT 38%, SCIT 41%) when compared with placebo4,5, persisting several years after withdrawal4,6. Immunotherapy may prevent new sensitizations and progression of rhinitis to asthma7-11. Allergen immunotherapy is generally well tolerated with few side effects, although a potential risk of anaphylactic reactions exists 12. A review of recent parallel meta-analyses on immunotherapy for grass pollen rhinitis suggests that the safety profile of AIT is superior to that of SCIT13.

The recommended length of immunotherapy with both SCIT and AIT is 3-5 years2, although the route of administration and the doses of allergen differ substantially. SCIT involves an up-dosing phase lasting 12-15 weeks with one or more weekly injections of increasing doses of allergen followed by a maintenance dose every 6-10 weeks. AIT starts with the daily maintenance dose, resulting in high cumulative doses. It is largely unknown whether the immunological mechanisms involved in the clinical effect are the same.

The changes in immunology have been extensively investigated for SCIT, and the most pronounced patterns are: 1) the induction of blocking antibodies, 2) a shift in Th1/Th2 balance towards Th1, and 3) induction of regulatory T cells. Similar mechanisms seem to be in play for AIT 14-16. Increases in allergen-specific non-IgE antibodies have been demonstrated in large trials of both SCIT and AIT treatment17,18, and studies have demonstrated that serum antibodies can reduce in vitro reactions mimicking allergic responses, such as IgE binding to allergen, IgE facilitated antigen presentation and basophil activation19-22, suggesting that both humoral and cellular effects play a role23.

The aim of the present study was to compare the effect of AIT and SCIT on antibody titers (IgE and IgG4), on allergen-IgE interaction in competition assays (IgE-blocking factor and FAP inhibition) and on effector cell activation (BAT). Nasal challenges were included to assess the changes in nasal response to grass pollen allergen.

Being tested
ALK Grazax 75,000 SQ-T "Phleum pratense", ALK AluTard 225 "Phleum pratense"

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALK Grazax 75,000 SQ-T "Phleum pratense"Drug

  • ALK AluTard 225 "Phleum pratense"Drug

Study groups in NCT01889875
Study groupRoleWhat they receive
Control groupNo interventionNot described
Subcutaneous Immunotherapy (SCIT)Active comparatorTreatment using ALK AluTard 225 "Phleum pratense"
Receives: Drug: ALK AluTard 225 "Phleum pratense"
Sublingual Allergen Immunotherapy Tablets (AIT)Active comparatorTreatment using ALK Grazax 75,000 SQ-T "Phleum pratense"
Receives: Drug: ALK Grazax 75,000 SQ-T "Phleum pratense"

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes over time in specific Antibodies

    IgE, IgG4

    Measured: 0, 1, 2, 3, 6, 7, 10, 12, and 15 months post treatment start

  2. Changes over time in Basophil Activation Test

    Measured: 0, 1, 3, 6, 7, 10, 12, and 15 months post treatment start

Secondary outcomes (1)
  1. Changes over time in Nasal Challenge symptoms

    Measured: 0, 3, 10, and 15 months post treatment start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2013 (estimated)
  2. Study startNov 2010
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01889875
Sponsor's protocol ID
Graesallergi
Status last verified
Jun 2013
First submitted
24 Jun 2013
Last updated
1 Jul 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Aasbjerg K, Backer V, Lund G, Holm J, Nielsen NC, Holse M, Wagtmann VR, Wurtzen PA. Immunological comparison of allergen immunotherapy tablet treatment and subcutaneous immunotherapy against grass allergy. Clin Exp Allergy. 2014 Mar;44(3):417-28. doi: 10.1111/cea.12241.

    PubMed 24734285

Questions about this trial

What is this clinical trial studying?

A study testing ALK Grazax 75,000 SQ-T "Phleum pratense" and ALK AluTard 225 "Phleum pratense" in people with Allergic Rhinitis Due to Grass Pollens, run by Bispebjerg Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes over time in specific Antibodies (time frame: 0, 1, 2, 3, 6, 7, 10, 12, and 15 months post treatment start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01889875, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2013.

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